NCT06326697

Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)

A Randomized, Single Oral Dose, Open Label, Two Sequence, Two Treatment, Four Periods, Full Replicate Crossover Study to Determine the Bioequivalence of Azacitidine 300 mg Film- Coated Tablets Versus Onureg® 300 mg Film-Coated Tablets for Adult Patients With Acute Myeloid Leukaemia (AML) Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Hikma Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated Tablets in adult patients with AML under fasting conditions

Conditions

• Acute Myeloid Leukaemia

Interventions

Type	Name	Description
DRUG	Azacitidine	Azacitidine 300 mg Film coated tablets
DRUG	Onureg	Azacitidine 300 mg Film coated tablets

Timeline

• Start date: 2024-05-02
• Primary completion: 2025-08-17
• Completion: 2025-08-28
• First posted: 2024-03-22
• Last updated: 2025-09-26

Locations

1 site across 1 country: Saudi Arabia